Data and Safety Monitoring Boards (DSMBs) deserve smarter software during clinical trials.

Cloud Concinnity® is custom built for clinical trial oversight.

Custom built by experts with decades of governance, regulatory, and healthcare industry expertise, Cloud Concinnity optimizes the data review and patient safety processes. With oversight of clinical trials more important than ever, we empower data monitoring committees by centralizing all patient information, communications, processes and reporting onto a single, secure hub.

A clinical trial management solution for data monitoring committees and dsmb data safety monitoring boards

ACCESS

Maintaining data integrity every step of the way has never been easier. And everything, from documents and templates to scheduling and reporting, can live securely in the cloud 24/7, allowing secure, self-service access and communication for all DSMB teams on clinical trials. With a single, secure hub, everyone always has access to the most updated versions. With strict DSMB software and role-based permissions, the division between blinded and unblinded data is always preserved.

• Virtual meeting capability is built into our integrated platform

• Smart folders, forms and templates available and uniform

• SOC 2 security certification and validated, 21 CFR Part 11 compliance ensures data integrity throughout

Secure Access & Communication for all DSMB Members

Automated Workflow Solution for Clinical Trial Oversight

PROCESS

Automated processes mean more efficient interactions, consistent application of best practices and significantly reduced risk of delays, errors and noncompliance. While other platforms may bring some paperwork online, our DSMB clinical trial management software takes the next step. Your DSMB can bring every interaction online, eliminating the costly and time-consuming work of scheduling and sharing work across platforms and time zones.

• Manage multiple trials and studies in a single platform

• Use a single platform to manage credentials of multiple DSMB teams across multiple clinical trials

• Task management with comprehensive notification and escalation support in a consolidated dashboard

OUTCOMES

Cloud Concinnity DSMB software is always audit-ready and simple to export, interactions are automatically documented and available for review anytime, and everything is always up to date. The beauty of a single, secure software hub that lives in the cloud is that you only have to do the work once and it updates everywhere. When it comes time to make decisions or deliver reports, everything is ready.

Enrollment reporting
AE notification reporting with aggregation
Export PDFs of the final version of all study documents

DSMB solution providing CROs, Sponsors, and Regulators proper communication between participants, in a single, secure environment.

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Single, secure hub for DSMB governance during clinical trials.

board management software offering agile team collaboration

PRODUCE, SHARE & STORE A SET OF STANDARD DSMB ORGANIZATIONAL DOCUMENTS

DSMB administrators need a way to produce, share and store standardized documents like charters, agendas, minutes and SMP letters during a clinical trial. Enrollment updates and adverse events of interest are also easily reported through the portal. Using a central, secure software hub eliminates the problem of templates or finalized documents being spread across multiple storage systems, while ensuring the consistency of documentation, keeping the process moving and reducing errors.

SCHEDULE TIMELY DSMB MEETINGS WITH QUORUMS & APPROPRIATE EXPERTISE IN ATTENDANCE

One of the biggest challenges for DSMB administrators during clinical trials, especially in the age of COVID-19, is managing the web of schedules for all key stakeholders. Eliminate countless emails and time-consuming delays by centralizing the entire process to get meetings scheduled in a timely way and keep the clinical trial on schedule.

An executive dashboard that enables members to access real-time performance metrics

Experience business process management in a whole new way

DISTRIBUTE DSMB CLINICAL TRIAL MEETING DOCUMENTS IN A TIMELY & SECURE MANNER

Smooth, efficient administration of all DSMB documents from a centralized hub streamlines productivity for the administrator and allows data and safety monitoring board members to feel well-supported so they can focus exclusively on their task of reviewing data.

SEGREGATE BLINDED VS. UNBLINDED DATA FOR OVERSIGHT OF CLINICAL TRIALS

Strict role-based permissions on a single source of truth mean blinded participants will never see unblinded data — it’s simply not possible. Automated data segregation replaces the time-consuming, manual management of sharing data with the Open and Closed Sessions, blinded and unblinded participants. This dramatically reduces the chances of unblinding and reduces the anxiety of sharing the wrong information for everyone on the data monitoring committee.

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ACCESS & TRACK CURRENT DSMB ENROLLMENT DATA

Proactively making everyone aware of the current enrollment data allows the DSMB to schedule its clinical trial meetings when most appropriate, expediting everyone’s work and keeping the study on schedule.

EFFICIENTLY ADMINISTER MULTIPLE DMSBs FOR CLINICAL TRIALS

Using a central, cloud-based hub, administrators can do more with less. A single administrator can support multiple clinical trials, centralizing productivity and risk management in a way that increases efficiency every step of the way for each DSMB.

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EXPORT DSMB CLINICAL TRIAL PDFS TO THE TRIAL MASTER FILE

Cloud Concinnity makes it easier to deliver a zipped folder of all final PDFs of DSMB documentation to a Trial Master File while deleting all previous draft documents. With a central, secure software hub, this process is efficient and smooth, replacing cumbersome manual processes of the past.

HOST & MANAGE VIRTUAL DSMB MEETINGS

Cloud Concinnity is the only DSMB software that enables video conference communication between members. Not only is it secure, but it also happens in the same secure environment where all documents and data live, meaning that all DSMB conversations during all clinical trials have secure access to all updated, relevant information.

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SUPPORT ADAPTIVE DSMB DESIGN WITH INFRASTRUCTURE

The DSMB plays an even larger, more critical clinical trial role in the fast-paced world of adaptive design. That increase in speed and flexibility requires better infrastructure to be responsive to the sponsor and still focus appropriate attention on data review.